Catheter assembly

ABSTRACT

A catheter assembly includes a catheter, part of which forms an insertable length to be inserted through a body opening and a catheter receptacle to accommodate at least part of the catheter such that an insertable portion of the catheter is enclosed but part of the catheter is left outside of the receptacle. Also disclosed is a method for producing a catheter assembly which includes providing a receptacle having an opening, providing a catheter which has a catheter tube and a connector on one end thereof, arranging the catheter tube in the receptacle, and connecting the receptacle to the connector to close the opening.

This application is a divisional of co-pending U.S. application Ser. No.10/487,912, filed Apr. 27, 2004, which is the national phase under 35U.S.C. § 371 of PCT International Application No. PCT/SE03/00681 whichhas an International filing date of Apr. 29, 2003, which designated theUnited States of America and which claims priority on Swedish PatentApplication No. 0201330-8, filed Apr. 30, 2002. The entire contents ofwhich are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to a catheter assembly comprising acatheter and a receptacle for accommodation of at least part of thecatheter. The invention further relates to a method for producing such acatheter assembly.

BACKGROUND OF THE INVENTION

Catheters find their use in many different medical applications, such asurinary catheters for bladder drainage. Catheters are normallypre-packed in a receptacle by the manufacturer, in order to maintain thecatheter in a clean and preferably sterile condition. However, a problemwith such catheter assemblies are that they are bulky, making themdifficult and expensive to store, transport and handle. Further, a lotof packaging and wrapping material is required, making the assembliesexpensive and harmful to the environment.

Urinary catheters in general need to have a lubricant applied to theouter surfaces thereof to facilitate insertion into the urethra.Especially, for lubrication purposes hydrophilic urinary catheters mayhave a hydrophilic outer surface coating which should be wetted by afluid such as water or saline for a certain time period prior toinsertion thereof into the urethra of a patient. In order to facilitatethe use and to improve cleanliness of the catheter, the assemblies havein recent years developed to comprise a rupturable wetting fluid pouchor container as well. This is e.g. known from WO 98/19729. However,unfortunately the inclusion of such a wetting fluid container makes theabove-described problem with bulkiness, etc, even more severe.

Further, there has recently been a trend towards so-called“ready-to-use” catheters, where the catheter is arranged in thereceptacle together with a wetting fluid, so that the catheter ismaintained in a wetted, activated condition. Such a catheter assembly ise.g. known from WO 00/47494. However, in such a catheter, a relativelylarge amount of wetting fluid is required to fill the receptacle to acertain degree and to ensure that an adequate wetting of the catheter ismaintained. accordingly, even this type of catheter assembly suffersfrom the bulkiness discussed above, and is further relatively heavy.Further, a problem with this type of catheter assemblies are that thecatheter becomes wet and slippery, which makes it uncomfortable anddifficult to handle.

There is further a problem with known catheter assemblies that thecatheter must normally be removed from the receptacle or package beforeit could be connected to other devices, such as drainage tubes, urinebags, etc. Hereby, the handling of the catheter becomes more difficult,since more work has to be done by the person responsible for thecatheterization, and especially during the stressed situation when thecatheter is exposed to the environment, instead of in advance, or evenas a step during the production process. Further, the time period whenthe catheter is exposed, and accordingly vulnerable to contamination andthe like, is prolonged, which increases the risk for the patient.

Accordingly, there is a need for a leaner and less bulky catheterassembly and/or a catheter assembly which is easier and more convenientto handle and/or a catheter assembly which is less expensive to produce,and especially for hydrophilic urinary catheters. The present inventiontherefore proposes to address this need. This object is achieved withthe catheter assembly and the method according to the appended claims.

SUMMARY OF THE INVENTION

According to one aspect of the invention, it relates to a catheterassembly comprising a catheter including a catheter tube and a connectorarranged in one end of the catheter tube; and a catheter receptacle foraccommodation of at least the catheter tube. Further, the receptacle isprovided with an opening, said opening being connected to and closed bythe connector of the catheter.

The term “connector” is, in the context of this application, to beunderstood in a broad sense, meaning any part of the catheterfunctioning as a means for connecting the catheter tube to externalmeans, such as external tubing, or simply functioning as an outlet fordrainage through the catheter tube. Further, the connector need not be aseparate part of the catheter, but could be integrated with the cathetertube.

Further, “end of the catheter”, is in the context of this application,also to be understood in a broad sense, meaning the end section of anypart projecting or protruding from the rest of the catheter.Consequently, a catheter may have more than two ends, and an end mustnot be positioned farthest away from the main body of the catheter inany direction.

With the catheter assembly according to the first aspect of theinvention, a very advantageous catheter assembly is provided. Generally,the invention relates to a catheter assembly, comprising a catheterreceiving receptacle and a catheter having a connector at one endthereof, wherein the receptacle is sealed by said connector. Since thereceptacle is closed by the connector of the catheter, only part of thecatheter is enclosed in the receptacle. Hereby, the assembly could bemade leaner and less bulky since a receptacle of smaller volume could beused, and at the same time less material is required making the assemblyeasier and less costly to manufacture. This also makes the product moreenvironment friendly, since less material is required. Still, all partsof the catheter intended to be inserted into the patient, i.e. allinsertable parts of the catheter, could nonetheless be kept in a sterileand medically safe condition, making this catheter assembly at least asreliable as previously known catheter assemblies where the wholecatheter is arranged inside the receptacle.

Further, by the arrangement with the receptacle being closed by theconnector of the catheter, whereby at least part of the connector can beaccessed from the outside of the receptacle, the catheter could beconnected to other devices, such as drainage tubes, urine bags, etc.before removal of the catheter from the receptacle or package. Hereby,the handling of the catheter becomes both simpler and safer, since theconnection work need not be done by the person responsible for thecatheterization, and especially not during the stressed situation whenthe catheter is removed from the receptacle and, thus, exposed to theenvironment. Hereby, the catheterization becomes easier and moreefficient, and the time period when the catheter is exposed, andaccordingly vulnerable to contamination and the like, is also shortenedsignificantly, which decreases the risk for the patient.

The connection of the catheter to other parts could, with the inventiveconcept, even be made already during production. Hereby, the productioncould comprise a module system, where the catheter assembly could beproduced as a standard component, which is connectable during productionwith other parts, such as drainage tubes, urine bags and the like, intodifferent end products. Hereby, the production could be made simpler andmore cost efficient, requiring less production machinery, less storages,etc. Hereby, the production also becomes more environment friendly.

Consequently, the invention relates to a catheter assembly comprising acatheter, part of which forms an insertable length to be insertedthrough a body opening; and a catheter receptacle for accommodation ofat least part of the catheter. Further, the receptacle is connected tothe catheter, thereby enclosing the insertable length of the catheter,but leaving at least part of the catheter outside the receptacle.

Further, by the arrangement of at least part of the connector outsidethe receptacle, the catheter could be connected to other devices, suchas drainage tubes, urine bags, etc. before removal of the catheter fromthe receptacle or package.

Some preferred embodiments of the above-discussed aspect of theinvention will now be discussed briefly. Preferably, the receptacle issealingly connected to the catheter, and/or the compartment formed bythe receptacle and the catheter is sealed. Hereby, at least aninsertable part of the catheter could be maintained in a clean, andpreferably sterile, condition during storage. Alternatively oradditionally, the compartment formed by the receptacle and the cathetercould form a microbial barrier against the environment.

The catheter is preferably a hydrophilic catheter. A hydrophiliccatheter is a catheter in which the catheter has, on at least a part ofits surface, a hydrophilic surface layer intended to be wetted with awetting fluid prior to use in order to provide a low-friction surface.

In case a hydrophilic urinary catheter is used in the catheter assembly,the assembly could further comprise a wetting fluid. Hereby, noadditional wetting fluid is needed for activation of the catheter, whichentails many advantages. For example, activation of the catheter couldeasily be accomplished in places where it is normally difficult to findan appropriate wetting fluid for this specific use. Further, it could beensured that only a sufficiently clean and sterile fluid is used,thereby decreasing the risk for unwanted contamination of the catheter.Still further, the wetting of the catheter may be accomplished in asimpler and more convenient manner.

In one line of embodiments, the catheter assembly comprises a containercontaining the wetting fluid, said container being arranged to keep thewetting fluid separated from at least the insertable part of thecatheter during storage and the container being openable for activationof the catheter. In such an embodiment, the wetting fluid may be keptseparated from the insertable part of the catheter, i.e. the part of thecatheter to be inserted through a body opening of the patient, until thetime when the catheter is intended to be used. Then, the wetting fluidcontainer may be opened, e.g. by application of a pressure, a pullingforce or the like to the container, whereby the wetting fluid is allowedto discharge into the compartment housing the catheter. The containermay be a compartment integrated with the receptacle, or a separatecontainer. In case a separate container is used, said container may bearranged completely inside the receptacle, partly inside the receptacleor outside the receptacle but preferably with some sort of fluidcommunication with the receptacle.

In another line of embodiments, the catheter assembly comprises acontainer containing the wetting fluid, said container being formed by acompartment of the receptacle housing the catheter, for preservation ofthe hydrophilic surface layer in a wetted state during accommodation insaid receptacle and provision of a so called “ready-to-use” catheterassembly. In such an embodiment, the catheter is continuously maintainedin an activated, ready-to-use condition.

In all embodiments where the catheter assembly comprises a wetting fluidcontainer, the amount of wetting fluid provided is preferably sufficientfor filling the receptacle to a certain degree and to ensure that anadequate wetting of the catheter is maintained.

In case the container is a compartment formed by the receptacle and thecatheter, said compartment is preferably gas sealed, wherein thelongevity of the product is increased. For the same reason, thereceptacle is preferably gas impermeable.

A suitable wetting fluid is sterile water or a saline solution.

It is further preferred that the receptacle of the catheter assemblyforms an elongate pocket.

The receptacle could be connected to the catheter by means of a weldingjoint, said joint preferably being arranged between the catheter and thereceptacle. This is a simple and cost effective way of providing a tightand sufficiently strong connection. Alternatively, the receptacle couldbe connected to the catheter by means of a shrink fit, which is also asimple and cost effective way of providing a tight and sufficientlystrong connection. The receptacle is preferably connected to theconnector of the catheter.

The receptacle of the catheter assembly preferably comprises openingmeans for opening of the receptacle, said opening means preferably beingarranged in an end of the receptacle being opposite to the connectionbetween the receptacle and the catheter. Hereby, unpacking of thecatheter before use becomes very easy. The opening means could comprisea peel-off joint, a tear line or the like.

A typical sterilizing agent which could be used for sterilizing thecatheter assembly of the invention is ethylene oxide. Moreover, thefluid in the fluid container would normally already be sterile whenpacked. For these reasons, the wetting fluid container is preferablymade of a material which is impermeable or substantially impermeable toethylene oxide as well as the fluid contained therein. Non-limitingexamples of materials satisfying this condition when the fluid is wateror saline are aluminium foil laminate, poly(vinylidene chloride) or alaminate comprising metallised film such as metallised poly(ethyleneterepthalate), or a silicon oxide coated film, or a laminate comprisingaluminum oxide. Other sterilization processes could of course be usedinstead, for example by irradiation. Steam treatment may also be usedfor sterilization.

According to another aspect of the invention, it relates to a method forproducing a catheter assembly, comprising: providing a receptacle havingan opening; providing a catheter including a catheter tube and aconnector arranged on one end thereof; arranging the catheter tube inthe receptacle; and connecting the receptacle to the connector, therebyclosing said opening.

With a production method according to this aspect of the invention,similar advantages are achieved as discussed above in relation to thefirst and second aspect of the invention.

Preferably, the catheter is first assembled by connecting the cathetertube and the connector, where after the catheter tube is arranged in thereceptacle and the receptacle is connected to the catheter connector.However, the manufacturing may also be in a reversed order. E.g. theconnector may be connected to the receptacle before assembly of theconnector and the catheter tube. In this case, the catheter tube maye.g. be introduced from another opening of the receptacle, which issubsequently closed.

According to another aspect of the invention, it relates to a catheterassembly comprising: a catheter having on at least part of its surface ahydrophilic surface layer intended to produce a low-friction surfacecharacter of the catheter by treatment with a wetting fluid prior to useof the catheter; a catheter receptacle forming a cavity foraccommodation of at least part of the catheter; and a compartmentaccommodating said wetting fluid, wherein said compartment forms anintegrated part of the receptacle, but being separated from said cavity.Further, an additional outer layer is attached to the receptacle, saidlayer being arranged to at least partly cover the part of the receptacleforming said wetting fluid compartment.

In accordance with this aspect of the invention, an additional cover isprovided in order to achieve a stronger and preferably gas impermeablewetting fluid compartment. Due to the use of this additional cover, therequirements on the material of the receptacle could be lowered, and thematerial need e.g. not be gas-impermeable. Hereby, the additional covercould provide the impermeability of the compartment wall necessary toalleviate evaporation and maintain the wetting fluid in the compartmentduring storage. At the same time, only a limited amount of covermaterial is needed, making the product cost effective to produce.

The additional cover may also be used as a protection for the wettingfluid against a sterilizing agent used for the sterilization of thecatheter and the rest of the catheter assembly. A typical sterilizingagent which could be used for sterilizing the wetting apparatus of theinvention is ethylene oxide. Moreover, the fluid in the fluid containerwould normally already be sterile when packed, and need not be furthersterilized. Additionally, the sterilizing agent may leave unwantedresidual products in the wetting fluid if exposed to the same. For thesereasons, it is preferred that the additional cover of the wetting fluidcontainer is made of a material which is impermeable or substantiallyimpermeable to ethylene oxide as well as the fluid contained therein.Non-limiting examples of materials satisfying this condition when thefluid is water or saline are aluminium foil laminate, poly(vinylidenechloride) or a laminate comprising metallised film such as metallisedpoly(ethylene terepthalate), or a silicon oxide coated film, or alaminate comprising aluminum oxide. Other sterilization processes couldof course be used instead, for example by irradiation in which case thefluid in the container could be sterilized in situ at the same time asthe rest of the components of the assembly. Steam treatment may also beused for sterilization.

The additional cover may be attached to the compartment by means of anadhesive, welding or any other suitable connection means.

According to a corresponding aspect, the invention further relates to amethod for producing a catheter assembly, comprising: providing areceptacle; providing a hydrophilic catheter; arranging at least part ofthe catheter tube in a cavity of the receptacle; arranging a wettingfluid in a compartment forming an integrated part of the receptacle, butbeing separated from said cavity; and attaching an additional outerlayer to the receptacle to at least partly cover the part of thereceptacle forming said wetting fluid compartment.

According to this method, similar advantages as discussed above areachieved.

According to another aspect of the invention, it relates to a catheterassembly comprising: a catheter having on at least part of its surface ahydrophilic surface layer intended to produce a low-friction surfacecharacter of the catheter by treatment with a wetting fluid prior to useof the catheter; a catheter receptacle forming a cavity foraccommodation of at least part of the catheter; and a compartmentaccommodating said wetting fluid, wherein said compartment forms anintegrated part of the receptacle, but being separated from said cavity,wherein the separation between the wetting fluid compartment and thecavity accommodating the catheter provides a rupturable sealed closure.Further, said closure is provided with at least one point of weakness,in order for an induced rupture to occur in a predetermined position,thereby enabling fluid communication between the compartment and thecavity housing the catheter.

In accordance with this embodiment of the invention, a rupture of thefluid compartment could be effectively controlled, in order for it tooccur in a predetermined position. Hereby, it could be avoided that thecompartment, upon application of pressure or the like, is ruptured in arandom position, which could lead to leakage of the fluid, insufficientwetting of the hydrophilic surface, etc. Instead, the rupture willalways occur in the most effective position, leading to an effectivewetting of the catheter surface.

Preferably, the closure is formed by a rupturable joint between thecompartments, and most preferably the joint is a welded joint with awelding width variation, or a welding strength variation, thus providingthe at least one point of weakness. Alternatively, the joint could bearranged in a non-linear arrangement, thus providing the at least onepoint of weakness. In this case, the joint could be arranged with atleast one knee directed towards the wetting fluid compartment. The kneecould e.g. have an angled peak portion directed towards the wettingfluid compartment, with an obtuse or acute angle. However, the knee mayalternatively have an curved peak portion directed towards the wettingfluid compartment. Hereby, effective rupture control may be achieved,and at the same time a very cost effective and easily producible jointis provided.

According to a corresponding aspect of the invention, a method isprovided for producing a catheter assembly, comprising: providing areceptacle; providing a hydrophilic catheter; arranging at least part ofthe catheter tube in a cavity of the receptacle; arranging a wettingfluid in a compartment forming an integrated part of the receptacle, butbeing separated from said cavity; and attaching an additional outerlayer to the receptacle to at least partly cover the part of thereceptacle forming said wetting fluid compartment.

All the various detailed embodiments and different features discussedabove in relation to different aspects of the invention discussed aboveare also usable together with the other aspects of the invention, andthus combinable in other ways than those specifically disclosed, ifnothing else is explicitly stated.

Further scope of the applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

By way of example embodiments of the invention will now be describedwith reference to the accompanying drawings in which:

FIG. 1 illustrates a first embodiment of a catheter assembly accordingto the invention, where FIG. 1 a is a partly broken view and FIG. 1 b isan unbroken view;

FIG. 2 is a partly broken side view of a second embodiment of a catheterassembly according to the invention;

FIG. 3 is a partly broken side view of a third embodiment of a catheterassembly according to the invention;

FIG. 4 is a partly broken side view of a fourth embodiment of a catheterassembly according to the invention;

FIG. 5 illustrates a fifth embodiment of a catheter assembly accordingto the invention, where FIG. 5 a is a side view of the whole catheterassembly, FIG. 5 b is an expanded view of the connector part of thecatheter assembly shown in FIG. 5 a, and FIG. 5 c is a view of theconnector part of FIG. 5 b illustrating the activation process;

FIG. 6 illustrates a sixth embodiment of a catheter assembly accordingto the invention, where FIG. 6 a is a side view of the whole catheterassembly, and FIG. 6 b is a view of the catheter assembly of FIG. 6 aillustrating the activation process;

FIG. 7 illustrates a seventh embodiment of a catheter assembly accordingto the invention, where FIG. 7 a is a side view of the whole catheterassembly, and FIG. 7 b is a view of the catheter assembly of FIG. 7 aillustrating the activation process;

FIG. 8 is a partly broken side view of a eight embodiment of a catheterassembly according to the invention;

FIG. 9 is a cross-section through the line IX-IX in FIG. 8; and

FIG. 10 illustrates different examples of a weakened joint separating awetting fluid compartment and a compartment housing the catheter in thereceptacle.

DESCRIPTION OF PREFERRED EMBODIMENTS

In the following detailed description preferred embodiments of theinvention will be described. However, it is to be understood thatfeatures of the different embodiments are exchangeable between theembodiments and may be combined in different ways, unless anything elseis specifically indicated.

General Description of the Catheter Assembly and Embodiments withExternally Accessible Connector

Referring first to FIG. 1, a first embodiment of a catheter assembly 1according to the invention comprises a wetting receptacle or bag 2,preferably of a transparent flexible plastics material. The receptacle 2has a downwardly extending elongate pocket 21 at the forward end and anopening end 22.

The catheter assembly 1 further comprises a catheter, and preferably ahydrophilic urinary catheter 3, having a preferably flared rearwardportion 31, an elongate shaft or tube 32 projecting forwardly from therearward portion 31 and an open-ended lumen (not shown) which extendsfrom the rear end of the rearward portion 31 to a drainage aperture 33in the rounded tip 34. The rearward portion 31 could function as aconnector of the catheter 3, being connectable to other devices, such asa urine collection bag, a drainage tube or the like. At least a part ofthe elongate tube 32 forms an insertable length to be inserted through abody opening of the user, such as the urethra in case of a urinarycatheter. By insertable length is normally, in the context of ahydrophilic catheter, meant the length of the elongate tube 32 which iscoated with a hydrophilic material, for example PVP, and which could beinserted into the urethra of the patient. Typically, this will be 80-140mm for a female patient and 200-350 mm for a male patient.

The catheter receptacle 2 is adapted for accommodation of the cathetertube 32 in the elongate pocket 21, and the opening of the opening end 22is connected to and closed by the connector or rearward end 31 of thecatheter. Hereby, the receptacle 2 encloses at least the insertablelength of the catheter 3, but leaves a part of the catheter 3 outsidethe receptacle.

The receptacle 2 preferably forms a sealed compartment around theaccommodated part of the catheter 3. Such a sealed compartment could beprovided by sealingly connecting the receptacle 2 to the catheter 3 andto close the lumen opening.

The receptacle 2 could be connected to the catheter 3 in various ways.For example, the connection could be provided by means of a weldingjoint arranged between the catheter and the receptacle. However, it isalso possible to connect the receptacle 2 to the catheter 3 by means ofa shrink fit, an adhesive or the like. In the disclosed embodiment, thereceptacle 2 is arranged on the outward side of the connector 31.However, the connector 31 may comprise a lower end protruding over apart of the elongate tube 32 of the catheter 3, and in such a case thereceptacle 2 may alternatively be connected to the inward side of saidprotruding part.

In the disclosed embodiment, the catheter lumen is closable be means ofa cap or cover 4 arranged to sealingly close the connector opening.However, other ways of providing a closure of the lumen are feasible aswell, such as arranging a breakable membrane somewhere in the lumen.

The receptacle 2 preferably comprises opening means for facilitatingopening of the receptacle in order to expose the catheter 3 for use. Theopening means could comprise a tear line 23 connected to a grippinghandle 24, such as a pulling tab. Hereby, the user could pull thegripping handle 24, and thereby tearing open the side wall of thereceptacle. Additionally, or alternatively, a gripping handle may bearranged in the opposite end of the tear line. However, alternativeopening means are also feasible, such as tear-lines arranged indifferent fashions, peel-off joints, etc. It is also possible toconstruct the receptacle so that it is openable by a screwing ortwisting action, e.g. by screwing or twisting open the end part of thereceptacle being opposite to the connector.

The receptacle preferably comprises a plate-like member 25, to be usedas a handle and gripping means. Such a member may also be used forcarrying printed information, such as one or several of the following: auser instruction, product name, batch number, producer identification,etc. In the disclosed embodiment, this plate-like member is arranged inthe end of the receptacle 2 being opposite to the catheter connector 31.

In a method of wetting the catheter 3 according to this embodiment, theuser opens the catheter compartment, i.e. the compartment of thereceptacle housing the catheter, and applies a wetting fluid onto theinsertable end for wetting of the catheter, thereby activating it forcatheterization. Different ways of wetting the catheter are feasible.For example, the assembly 1 may be opened in the connector end, byremoving the cap 4, whereafter the wetting fluid may be introducedthrough the catheter lumen. After the activation, the receptacle 2 maybe teared opened in order to expose the catheter for insertion into apatient. Alternatively, the receptacle 2 may be opened directly wherebythe catheter 3 is exposed and the wetting fluid may be applied directlyonto the catheter surface.

Being opened, the receptacle could either be ripped off and thendisposed of, or be maintained connected to the catheter. In case thereceptacle is intended to be ripped of, areas of weakness could bearranged to facilitate the removal of the receptacle. The receptaclecould either be separated from the catheter at the connection betweenthe catheter and the receptacle, or be teared apart, in which case apart of the receptacle will remain connected to the catheter.

When activated and with at least its distal end removed from thereceptacle 2, the catheter 3 could then be inserted into the urethra ofthe patient.

With reference to FIG. 2, a second embodiment of the catheter assemblywill now be discussed. In this embodiment, the catheter assemblygenerally corresponds to the first embodiment. However, in thisembodiment the assembly also comprises a wetting fluid container 250containing a wetting fluid 260. The wetting fluid container is formed ina separate compartment of the receptacle, and between the wetting fluidholding compartment and the compartment holding the catheter, arupturable separation wall 251 is arranged. The separation wall may beprovided by arranging a peelable joint between the compartments.

At least the part of the receptacle forming the wetting fluid container250 is preferably gas sealed and formed by a gas impermeable material.For example one or several of the following gas impermeable materialscould be used: aluminium foil laminate, poly(vinylidene chloride) orlaminate comprising a metallised film, such as metallised poly(ethyleneterepthalate), or silicon oxide coated film, or a laminate comprisingaluminum oxide.

The wetting fluid is preferably sterile water or a saline solution.

In a method of wetting the catheter according to this embodiment, theuser applies a compressing force to the wetting fluid container 250 insuch a way that the rupturable separation wall is opened and wettingfluid is introduced into the catheter compartment. Preferably, thewetting fluid container 250 contains a sufficient amount of wettingfluid for the insertable length of the catheter to be sufficientlywetted.

After release of the wetting fluid into the catheter compartment thereceptacle could be opened, where after the catheter could be exposedand used for catheterization. The receptacle could either be ripped offand then disposed of, or be maintained connected to the catheter.

With reference to FIG. 3, a third embodiment of the catheter assemblywill now be discussed. In this embodiment, the catheter assemblygenerally corresponds to the second embodiment in that it also comprisesa wetting fluid container 350 containing a wetting fluid 360. In thiscase, however, the wetting fluid container 360 is not formed in aseparate compartment of the receptacle, but is integrated with thecompartment holding the catheter. Hereby, the catheter is activatedalready during production, and is then maintained in a activated,ready-to-use condition. Thus, in this embodiment, the hydrophilicsurface layer is preserved in a wetted state during accommodation in thereceptacle and a ready-to-use catheter assembly is provided. In order topreserve this wetted condition the compartment formed by the receptacleand the catheter is preferably gas sealed, and further, the receptacleis preferably gas impermeable.

In use, the receptacle is simply opened, and the catheter couldimmediately be introduced into the patient.

With reference to FIG. 4, a fourth embodiment of the catheter assemblywill now be discussed. In this embodiment, the catheter assemblygenerally corresponds to the second embodiment in FIG. 2 in that it alsocomprises a wetting fluid container 450 containing a wetting fluid 460.In this case, however, the wetting fluid container 450 is formed in aseparate compartment being separated from, and arranged outside thereceptacle. The fluid container 450 is arranged on the connector, and afluid connection between the fluid container and the cathetercompartment is prevented by a rupturable separation wall 451. Theseparation wall could e.g. be a breakable or peelable membrane wallarranged over an opening of the fluid container. The separation wallcould be arranged to be broken upon application of a twist, acompression, a pull or the like on the fluid container. The fluidcontainer is preferably sealingly arranged in the opening end of theconnector, thereby also functioning as a cover to maintain the cathetercompartment in a sealed condition. It is also possible to arrange therupturable separation wall 451 connected to the connector of thecatheter, in which case the wall e.g. may be broken by depressing thefluid container further into the connector.

In a method of wetting the catheter according to this embodiment, theuser applies e.g. a compressing force to the wetting container in such away that the rupturable separation wall is opened and wetting fluid isintroduced into the catheter compartment through the catheter lumen.Preferably, the wetting container contains a sufficient amount ofwetting fluid for the insertable length of the catheter to besufficiently wetted.

After release of the wetting fluid into the catheter compartment, thefluid container 450 could be discarded and the receptacle could beopened, where after the catheter could be exposed and used forcatheterization. The receptacle could either be ripped off and thendisposed of, or be maintained connected to the catheter.

With reference to FIG. 5, a fifth embodiment of the catheter assemblywill now be discussed. In this embodiment, the catheter assembly 510comprises a wetting receptacle or bag 520, preferably of a transparentflexible plastics material. The receptacle 520 has a downwardlyextending elongate pocket 521 at the forward end and an opening end 522(see FIG. 5 b).

As in the previously discussed embodiments, the catheter assembly 510further comprises a catheter, and preferably a hydrophilic urinarycatheter 530. However, in this case a different type of connector 531 isused, with a different type of connection interface for connection toother devices, such as a urine collection bag a drainage tube or thelike.

The catheter receptacle 520 is adapted for accommodation of the cathetertube in the elongate pocket 521, and the opening of the opening end 522is connected to and closed by the connector or rearward end 531 of thecatheter. Hereby, the receptacle encloses at least the insertable lengthof the catheter 530, but leaves at least part of the catheter outsidethe receptacle, said part comprising the connection interface.

As discussed previously, the lumen could be closable by means of a capor cover arranged to sealingly close the connector opening. However, inthis embodiment it is preferred that a breakable membrane is arrangedsomewhere in the lumen, and preferably close to the connectioninterface. Hereby, the membrane could be arranged to break automaticallywhen connecting the connector to corresponding connection unit of adevice to be connected to the catheter.

In this embodiment the assembly also comprises a wetting fluid container550 containing a wetting fluid 560. In this case, the wetting fluidcontainer is formed in a compartment being integrated with theconnector. Preferably at least some of the compartment walls 520 areintegrated in connector unit, whereas at least one wall 510 is formed bythe receptacle. The wall formed by the receptacle could in this caseform the rupturable separation wall.

In the disclosed embodiment in FIG. 5, one side wall of the wettingfluid container 550 is formed by the wall 531 forming the connectioninterface and three side walls 552 are formed integrated with theconnector and arranged inside the receptacle. Further, one bottom wall554 is formed integrated with the connector, whereas the top wall isformed as a separation wall formed by the receptacle. In the compartmentformed by said walls the wetting fluid is stored. Preferably, thecompartment is formed around the catheter lumen, and in that case, atube 553 is arranged in the compartment for provision of a fluidcommunication between the connector interface and the elongate tube ofthe catheter. The wetting fluid container is openable in order to allowthe wetting fluid to discharge from the wetting fluid container into theelongate pocket of the receptacle for wetting of the catheter. Forexample, such an openable container may be provided by making theconnection between the separation wall and the rest of the containerpeelable. Hereby, the separation wall may be peeled opened by applying arelative force between the separation wall and the rest of thecontainer, whereby the wetting fluid is discharged into the rest of thereceptacle. The application of such a force may be provided by provisionof a handle 526 or the like. In that case, a pulling force may beapplied to the handle 526 in relation to the rest of the receptacle,whereby the separation wall 555 is peeled open from the container. Thisis illustrated schematically in FIG. 5 c.

Even in this embodiment the receptacle comprises opening means forfacilitating opening of the receptacle in order to expose the catheterfor use. The opening means could comprise one or several areas ofweakness, such as tear lines 523 a, 523 b connected to one or severalgripping handles 524, such as a pulling tab.

To facilitate the removal of the catheter from the receptacle and theinsertion into the urethra of the patient, at least one area of weakness523 a, 523 b, such as a tear line, is preferably arranged on thereceptacle in the area of the elongate pocket arranged to receive thefluid, in which the catheter is placed. Most preferably, two such areasof weakness 523 a, 523 b are provided, and separated in the lengthwisedirection of the receptacle. The intermediate part of the receptacle maybe used as an insertion aid for guiding and holding the wetted catheterwhen it is inserted into the urethra. There is therefore no need todirectly handle the catheter 530 for insertion thereof into the urethra,which is an advantage as the outer surface of the catheter 530 will beslippery due to the wetting procedure and therefore difficult to gripand furthermore because the possibility of contamination of the catheter503 at this stage is avoided, whereby the cleanness and sterility of thecatheter may be maintained.

Pulling tabs 524, 525 may be arranged on one or both sides of the areaof weakness, in order to facilitate tearing open of the receptacle.

In a method of wetting the catheter according to this embodiment, theuser applies e.g. a pulling force to the handle 526, thereby peelingopen the separation wall 555 and discharging the wetting fluid into thecatheter compartment. Preferably, the wetting fluid container contains asufficient amount of wetting fluid for the insertable length of thecatheter to be sufficiently wetted.

After release of the wetting fluid into the catheter compartment thereceptacle may be opened and part of it may even be used as anapplicator, as is discussed above.

With reference to FIG. 6, a sixth embodiment of the catheter assemblywill now be discussed. In this embodiment, the catheter assembly 610comprises a wetting receptacle or bag 620, preferably of a transparentflexible plastics material. The receptacle 620 has a downwardlyextending elongate pocket 621 at the forward end and an opening part 622with an opening.

As in the previously discussed embodiments, the catheter assemblyfurther comprises a catheter, and preferably a hydrophilic urinarycatheter 630, with a connection interface for connection to otherdevices, such as a urine collection bag a drainage tube or the like. Thecatheter receptacle 620 is adapted for accommodation of the cathetertube in the elongate pocket 621, and the opening of the opening part 622is connected to and closed by the connector 631 or rearward end of thecatheter. Hereby, the receptacle encloses at least the insertable lengthof the catheter, but leaves at least part of the catheter outside thereceptacle, said part comprising the connection interface.

As discussed previously, the lumen could be closable by means of a capor cover arranged to sealingly close the connector opening. However, inthis embodiment it is preferred that a breakable membrane is arrangedsomewhere in the lumen, and preferably close to the connectioninterface. Hereby, the membrane could be arranged to break automaticallywhen connecting the connector to corresponding connection unit of adevice to be connected to the catheter.

The assembly also comprises a wetting fluid container 650 containing awetting fluid 660. In this case, the wetting fluid container is formedin a compartment of the receptacle being separated from the compartmentaccommodating the catheter. The wetting fluid container 650 is in thisembodiment arranged in a part of the receptacle extending rearwardlyfrom the catheter, i.e. behind the connector part of the catheter. Saidrearward part of the receptacle is preferably in fluid communicationwith the forward part housing the catheter. This fluid communication maybe provided by the arrangement of at least one channel 626 past thecatheter connector. Preferably, two such channels 626 are arranged, oneon each side of the connector. Thereby the receptacle frames an opening627 in which the protruding part of the catheter is situated.

The wetting fluid compartment of the receptacle is separated from thecompartment holding the catheter by means of a rupturable separationwall 651. The separation wall 651 may be formed by a separable jointbetween the compartments, such as weld of less strength than the otherwelds forming the compartment. Hereby, the wetting fluid may bedischarged into the other compartment of the receptacle by compressingthe wetting fluid container, or by applying a pulling force between theend parts of the assembly.

In order to achieve a stronger and preferably gas impermeable wettingfluid compartment, it is preferred to arrange an additional cover 660around said compartment. This additional cover could be arranged on theinside of the compartment formed in the receptacle, but is preferablyarranged as an outer cover arranged over the wetting fluid compartmentpart of the receptacle. Such an additional cover is very advantageous,and this concept is discussed in more detail later.

Even in this embodiment the receptacle could comprise opening means forfacilitating opening of the receptacle in order to expose the catheterfor use. The opening means could comprise one or several areas ofweakness, such as tear lines 623 a, 623 b connected to one or severalgripping handles 624 a, such as a pulling tab. Said opening means couldbe used to facilitate the removal of the catheter from the receptacleand the insertion into the urethra of the patient.

Further, alternatively or additionally, opening means may be arrangedclose to the distal end of the catheter. Said opening means may comprisea peelable joint 623 c connected to tabs 624 b extending from the edgefor enabling opening by peeling the tabs apart, thereby separating thefoil walls of the receptacle. Preferably, the receptacle is arranged toallow a significant degree of separation of the foil walls, therebymaking it possible to expose an essential part, and preferably thewhole, insertable part of the catheter during this opening process.There is therefore no need to directly handle the catheter 630 duringthe insertion thereof into the urethra, which is an advantage as theouter surface of the catheter 630 will be slippery due to the wettingprocedure and therefore difficult to grip, and furthermore because thepossibility of contamination of the catheter at this stage is avoided,whereby the cleanness and sterility of the catheter may be maintained.

At least one, and preferably both, of the end parts of the catheterassembly are preferably provided with gripping means, such as openings670, for facilitating handling of the catheter assembly.

In a method of wetting the catheter according to this embodiment, theuser applies e.g. a compressing force to the wetting fluid compartment650, thereby forcing open the separation joint 651 and discharging thewetting fluid into the catheter compartment, as is illustrated in FIG. 6b. Preferably, the wetting fluid container contains a sufficient amountof wetting fluid for the insertable length of the catheter to besufficiently wetted.

After release of the wetting fluid into the catheter compartment thereceptacle may be opened, e.g. at the distal end, as is discussed above,for insertion of the catheter.

With reference to FIG. 7, a seventh embodiment of the catheter assemblywill now be discussed. In this embodiment, the catheter assembly 710comprises a wetting receptacle or bag 720, preferably of a transparentflexible plastics material. The receptacle 720 has a downwardlyextending elongate pocket 721 at the forward end and an opening part 722with an opening.

As in the previously discussed embodiments, the wetting apparatusfurther comprises a catheter, and preferably a hydrophilic urinarycatheter 730, with a connection interface for connection to otherdevices, such as a urine collection bag a drainage tube or the like. Thecatheter receptacle is adapted for accommodation of the catheter tube inthe elongate pocket 721, and the opening of the opening part 722 isconnected to and closed by the connector or rearward end of thecatheter. Hereby, the receptacle encloses at least the insertable lengthof the catheter, but leaves at least part of the catheter outside thereceptacle, said part comprising the connection interface.

As discussed previously, the lumen could be closable by means of a capor cover arranged to sealingly close the connector opening. However, asin the sixth embodiment it is preferred that a breakable membrane isarranged somewhere in the lumen, and preferably close to the connectioninterface.

Even in this embodiment the receptacle could comprise opening means forfacilitating opening of the receptacle in order to expose the catheterfor use. The opening means could comprise one or several areas ofweakness, such as tear lines 723 a, 723 b connected to one or severalgripping handles 724 a, such as a pulling tab. Said opening means couldbe used to facilitate the removal of the catheter from the receptacleand the insertion into the urethra of the patient

Further, alternatively or additionally, opening means may be arrangedclose to the distal end of the catheter. Said opening means may comprisea peelable joint 723 c connected to tabs 724 b extending from the edgefor enabling opening by peeling the tabs apart, thereby separating thefoil walls of the receptacle. Preferably, the receptacle is arranged toallow a significant degree of separation of the foil walls, therebymaking it possible to expose an essential part, and preferably the wholeinsertable part of the catheter during this opening process. There istherefore no need to directly handle the catheter 730 for insertionthereof into the urethra, which is an advantage as the outer surface ofthe catheter will be slippery due to the wetting procedure and thereforedifficult to grip and furthermore because the possibility ofcontamination of the catheter at this stage is avoided, whereby thecleanness and sterility of the catheter may be maintained.

At the other end of the receptacle, preferably arranged relatively closeto proximal end of the catheter, further opening means may be arranged,comprising e.g. a peelable joint 723 d connected to tabs 724 c extendingfrom the edge for enabling opening by peeling the tabs apart, therebyseparating the foil walls of the receptacle. Said opening means may beused for the provision of a wetting fluid introduction opening forintroduction of a wetting fluid into a wetting fluid receivingcompartment of the receptacle when the catheter is to be wetted andactivated before use.

The opening means for providing the wetting fluid introduction openingis preferably arranged in a part of the receptacle extending rearwardlyfrom the catheter, i.e. behind the connector part of the catheter. Saidrearward part of the receptacle is preferably in fluid communicationwith the forward part housing the catheter. This fluid communication maybe provided by the arrangement of at least one channel 726 past thecatheter connector. Preferably, two such channels 726 are arranged, oneon each side of the connector. Thereby the receptacle frames an opening727 in which the protruding part of the catheter is situated. With thisconstructional arrangement, the wetting fluid introduction opening couldbe made relatively large, which facilitates the introduction of thewetting fluid.

At least one, and preferably both, of the end parts of the catheterassembly are preferably provided with gripping means, such as openings770, for facilitating handling of the catheter assembly.

In a method of wetting the catheter according to this embodiment, theuser opens the wetting fluid introduction opening by pulling the tabs724 c apart, thereby forcing open the peelable joint 723 d. Thereafter,a wetting fluid could easily be introduced into the cathetercompartment, as is illustrated in FIG. 7 b.

After introduction of the wetting fluid into the catheter compartmentthe receptacle may be opened further, e.g. at the distal end, as isdiscussed above, for insertion of the catheter into the patient.

The catheter assemblies as discussed above could be sterilized usingethylene oxide. In case the assembly comprises a container with awetting fluid, such as sterile water or saline, there sterilizing of thecontents of the container is normally both unnecessary and unwanted.Accordingly, the material of the container is preferably impermeable toethylene oxide and water. Non-limiting examples of materials meetingthese requirements are poly(vinylidene chloride) (PVDC), aluminium foillaminates or a laminate comprising a metallised film, for examplemetallised poly(ethylene terepthalate), or a silicon coated film. Othersterilization processes could of course be used instead, for example byirradiation in which case the fluid in the container could be sterilizedin situ at the same time as the rest of the components of the assembly.Steam treatment may also be used for sterilization.

Production of the different catheter assemblies discussed above isrelatively simple. Basically, the production method comprises the stepsof providing a receptacle having an opening and a catheter. Thereafter,the catheter is partly introduced into the receptacle, and thereceptacle is connected to the catheter, thereby closing said opening,with at least a part of the catheter protruding out from the receptacle.

In the assemblies discussed above, the receptacle may actually beregarded as a receptacle where part of the receptacle is formed by apart of the catheter. However, this is not applicable for the examplesdescribed with reference to FIG. 8-10, discussed in the following.

Catheter Assemblies Having a Wetting Fluid Container with AdditionalCover

As is already discussed above with reference to FIG. 6, the arrangementof an additional cover 660 around the wetting fluid compartment of thereceptacle is advantageous.

This additional cover could be arranged on the inside of the compartmentformed in the receptacle, but is preferably arranged as an outer coverarranged over the wetting fluid compartment part of the receptacle. Dueto the use of this additional cover, the requirements on the material ofthe receptacle could be lowered, and the material need e.g. not begas-impermeable. Hereby, the additional cover could provide theimpermeability of the compartment wall necessary to alleviateevaporation and maintain the wetting fluid in the compartment duringstorage.

The additional cover may also be used as a protection for the wettingfluid against a sterilizing agent used for the sterilization of thecatheter and the rest of the catheter assembly. A typical sterilizingagent which could be used for sterilizing the wetting apparatus of theinvention is ethylene oxide. Moreover, the fluid in the fluid containerwould normally already be sterile when packed, and need not be furthersterilized. Additionally, the sterilizing agent may leave unwantedresidual products in the wetting fluid if exposed to the same. For thesereasons, it is preferred that the additional cover of the wetting fluidcontainer is made of a material which is impermeable or substantiallyimpermeable to ethylene oxide as well as the fluid contained therein.Non-limiting examples of materials satisfying this condition when thefluid is water or saline are aluminium foil laminate, poly(vinylidenechloride) or a laminate comprising metallised film such as metallisedpoly(ethylene terepthalate), or a silicon oxide coated film, or alaminate comprising aluminum oxide,

The additional cover may be attached to the compartment by means of anadhesive, welding or any other suitable connection means.

Accordingly, in a production method of this catheter assembly, thereceptacle is manufactured, and the catheter is arranged in thereceptacle, as is discussed in more detail below. Further, the wettingfluid is introduced into the wetting fluid compartment, and theadditional cover is arranged outside said compartment. Then, theassembly could be sterilized, whereby the additional cover serves as aprotection for the wetting fluid against the sterilizing agent.

The additional cover as discussed above could also be used for othertypes of catheter assemblies, such as assemblies where the catheter isfully enclosed in the receptacle, or where the connector of the catheteris arranged in a separate compartment of the receptacle.

With reference to FIG. 8, an eight embodiment of the catheter assemblywill now be discussed. This embodiment to a large extent resembles theembodiment discussed with reference to FIG. 6. The most importantdifferences between the embodiments in FIG. 8 and FIG. 6 are that thewhole catheter is enclosed in the receptacle in the embodiment in FIG.8, and that the wetting fluid compartment is configured somewhatdifferently.

In this embodiment, the catheter assembly 810 comprises a wettingreceptacle or bag 820, preferably of a transparent flexible plasticsmaterial. The receptacle 820 has a downwardly extending elongate pocket821 at the forward end.

As in the previously discussed embodiments, the catheter assemblyfurther comprises a catheter, and preferably a hydrophilic urinarycatheter 830, with a connection interface for connection to otherdevices, such as a urine collection bag a drainage tube or the like. Thecatheter receptacle 820 is adapted for accommodation of the catheter,and at least the catheter tube is accommodated in the elongate pocket821. Hereby, the receptacle in this embodiment encloses the whole lengthof the catheter.

The assembly also comprises a wetting fluid container 850 containing awetting fluid (not illustrated). The wetting fluid container is formedin a compartment of the receptacle being separated from the compartmentaccommodating the catheter. The wetting fluid container 850 is in thisembodiment arranged in a part of the receptacle extending rearwardlyfrom the catheter, i.e. behind the connector part of the catheter. Saidrearward part of the receptacle is preferably in fluid communicationwith the forward part housing the catheter. This fluid communication maybe provided by the compartment of the receptacle housing the catheterbeing rearwardly open towards the separation to the wetting fluidcontainer.

The wetting fluid compartment of the receptacle is separated from thecompartment holding the catheter by means of a rupturable separationwall 851. The separation wall 851 is in this case formed by a separablejoint between the compartments, such as is discussed in more detail inthe following. Hereby, the wetting fluid may be discharged into theother compartment of the receptacle by compressing the wetting fluidcontainer, or by applying a pulling force between the end parts of theassembly.

In order to achieve a stronger and preferably gas impermeable wettingfluid compartment, an additional cover 860 is arranged around saidcompartment. This additional cover is arranged as an outer coverarranged over the wetting fluid compartment part of the receptacle. Suchan additional cover is very advantageous, and this concept has alreadybeen discussed in more detail with reference to FIG. 6.

In this embodiment, two sheets of outer cover material is arranged overthe part of the receptacle forming the wetting fluid container.Preferably, the outer cover material sheets are dimensioned essentiallyonly to cover the wetting fluid container part of the receptacle.However, larger sheets, possibly covering the whole receptacle areconceivable, as well as smaller sheets, possibly only covering a part ofthe wetting fluid compartment. Further, a folded sheet of cover materialmay be used as an alternative two the two separate sheets discussedabove.

The attachment of the outer cover could be provided in different manner,as has already been discussed. In this embodiment, the cover sheets arewelded to the receptacle at the ends are of the sheets, as is bestvisible in the cross-sectional illustration of FIG. 9. Accordingly, thesheets are preferably welded to the receptacle close to the weldsforming the receptacle.

Even in this embodiment the receptacle could comprise opening means forfacilitating opening of the receptacle in order to expose the catheterfor use. The opening means could comprise one or several areas ofweakness, such as tear lines 823 a, 823 b connected to one or severalgripping handles 824 a, 824 a′, such as a pulling tab. Said openingmeans could be used to facilitate the removal of the catheter from thereceptacle and the insertion into the urethra of the patient.

Further, alternatively or additionally, opening means may be arrangedclose to the distal end of the catheter. Said opening means may comprisea peelable joint 823 c connected to tabs 824 b extending from the edgefor enabling opening by peeling the tabs apart, thereby separating thefoil walls of the receptacle. Preferably, the receptacle is arranged toallow a significant degree of separation of the foil walls, therebymaking it possible to expose an essential part, and preferably thewhole, insertable part of the catheter during this opening process.There is therefore no need to directly handle the catheter 830 duringthe insertion thereof into the urethra.

At the other end of the receptacle, preferably arranged relatively closeto proximal end of the catheter but on the other side of the wettingfluid compartment, further opening means may be arranged, comprisinge.g. a peelable joint 823 d connected to tabs 824 c extending from theedge for enabling opening by peeling the tabs apart, thereby separatingthe foil walls of the receptacle. Said opening means may be used for theremoval of the catheter from the proximal end after the release of thewetting fluid.

At least one, and preferably both, of the end parts of the catheterassembly are preferably provided with gripping means, such as openings870, for facilitating handling of the catheter assembly.

The method of wetting the catheter according to this embodimentresembles the wetting process discussed with reference to FIG. 6. Afterrelease of the wetting fluid into the catheter compartment thereceptacle may be opened, e.g. at the distal end, as is discussed above,for insertion of the catheter.

Catheter Assemblies Having a Wetting Fluid Container with ImprovedRupture Control

A catheter assembly is e.g. disclosed in FIG. 6 as comprising ahydrophilic catheter, a catheter receptacle forming a cavity foraccommodation of at least part of the catheter and a compartmentaccommodating said wetting fluid, wherein said compartment forms anintegrated part of the receptacle, but being separated from said cavity.In this type of catheter assembly, it is advantageous if the separationbetween the wetting fluid compartment and the cavity accommodating thecatheter provides a rupturable sealed closure, in which it is providedat least one point of weakness, in order for an induced rupture to occurin a predetermined position, thereby enabling fluid communicationbetween the compartment and the cavity housing the catheter.

In the assembly of FIG. 6, a wetting fluid container 650 is formed in acompartment of the receptacle being separated from the compartmentaccommodating the catheter. The wetting fluid container 650 is in thisembodiment arranged in a part of the receptacle extending rearwardlyfrom the catheter, i.e. behind the connector part of the catheter. Saidrearward part of the receptacle is preferably in fluid communicationwith the forward part housing the catheter. The wetting fluidcompartment of the receptacle is separated from the compartment holdingthe catheter by means of a rupturable separation wall 651. Theseparation wall 651 may be formed by a separable joint between thecompartments, such as weld of less strength than the other welds formingthe compartment. Consequently, a whole segment of the total weld jointis weakened, viz. the part of the joint facing the catheter compartment.When a rupture is induced, e.g. by manual compression of the wettingfluid compartment or by applying a pulling force between the end partsof the assembly, the rupture will inevitably occur in this predeterminedposition, thus ensuring the intended functionality of the catheterassembly product.

In order to achieve an even better control of the rupture process, thearea of weakness could be even narrower. It is preferred that theweakness is maximized in a limited number of discrete points, such as inone, two or three maxima. However, the points of weakness may also beevenly distributed over a limited area. In that case, it is preferred ifthe area of weakness is distributed over less than 10% of the jointlength, and more preferably over less than 5%, and most preferably overless than 1%.

In the example of FIG. 6 the weakness has a maximum narrowed down toessentially one point of the length of the joint. This is achieved bymeans of a non-linear geometrical arrangement of the joint. The joint ishere arranged with a knee directed towards the wetting fluidcompartment. The knee has an angled peak portion directed towards thewetting fluid compartment, with an obtuse angle. The peak portiondefines the area of maximal weakness, and consequently the rupture willinevitably commence in this point, leading to a controllable andpredictable rupture process.

In the embodiment discussed above in relation to FIG. 8, a similararrangement is provided. In this embodiment, the rupturable separationwall 851 is likewise formed by a separable joint between thecompartments, whereby the wetting fluid may be discharged into the othercompartment of the receptacle by compressing the wetting fluidcontainer, or by applying a pulling force between the end parts of theassembly. In this embodiment this is achieved by means of a non-lineargeometrical arrangement of the joint together with a weld widthvariation. The joint is here arranged with a knee directed towards thewetting fluid compartment. The knee has an angled peak portion directedtowards the wetting fluid compartment, with an acute angle. The peakportion defines the area of maximal weakness, and consequently therupture will inevitably commence in this point, leading to acontrollable and predictable rupture process. Further, this effect issupported and increased by an advantageously arranged width variation ofthe weld. In this embodiment, the width of the weld is at a minimum atthe peak area, and gradually increases towards the ends. Hereby, thestrength of the weld is at a minimum at the peak-area, coinciding withthe separation force being maximized at the same position due to thegeometrical arrangement of the weld. Accordingly, the two parameters,weld width and geometrical arrangement, cooperates to form a verypredictable and easily ruptured separation wall.

Many different alternatives are conceivable to form the desiredrupturable joint between the compartments. Some of these alternativeswill now be discussed with reference to FIG. 10.

In FIG. 10 a, a separation joint is illustrated comprising a kneedirected towards the wetting fluid compartment. The knee has an angledpeak portion directed towards the wetting fluid compartment, with anobtuse angle. The peak portion defines the area of maximal stressbuild-up, and accordingly the area of maximal weakness, and consequentlythe rupture will inevitably commence in this point, leading to acontrollable and predictable rupture process.

In FIG. 10 b, a separation joint is illustrated comprising a widthvariation of the weld. In this embodiment, the width of the weld is at aminimum essentially at the center of the joint, and gradually increasestowards the ends. Hereby, the strength of the weld is at a minimum wherethe width is the smallest, and consequently the rupture will inevitablycommence in this point, leading to a controllable and predictablerupture process.

In FIG. 10 c, a separation joint is illustrated comprising a kneedirected towards the wetting fluid compartment. The knee has a inwardlycurved peak portion, directed towards the wetting fluid compartment. Thepeak portion defines the area of maximal stress build-up, andaccordingly the area of maximal weakness, and consequently the rupturewill inevitably commence in this point, leading to a controllable andpredictable rupture process.

In FIG. 10 d, a separation joint is illustrated comprising a double kneedirected towards the wetting fluid compartment. The joint has two angledpeak portion directed towards the wetting fluid compartment, with acuteangles. The peak portions defines the area of maximal stress build-up,and accordingly the area of maximal weakness, and consequently therupture will inevitably commence in one, or both, of these points,leading to a controllable and predictable rupture process.

In FIG. 10 e, a separation joint is illustrated comprising two welds,wherein a discontinuity is arranged in one of the welds. In thisembodiment, an interruption is arranged in the innermost weld, andessentially in the center of the joint. Hereby, the strength of thejoint is at a minimum at the discontinuity area, and consequently therupture will inevitably commence in this area, leading to a controllableand predictable rupture process.

In FIG. 10 f, a separation joint is illustrated comprising a weldcomprising different qualities or weld strengths. In this embodiment, apart of the weld is of a poorer quality and less strength that the restof the weld, and this part is positioned essentially in the center ofthe joint. Hereby, the strength of the joint is at a minimum at the areaof the weaker weld, and consequently the rupture will inevitablycommence in this area, leading to a controllable and predictable ruptureprocess.

Naturally, other alternatives are conceivable as well. Further, it isalso possible to combine two or more of the alternatives, as is e.g. thecase with the embodiment discussed in relation to FIG. 8.

CONCLUSION AND SUMMARY

The invention has now been discussed in relation to differentembodiments. However, it should be appreciated by someone skilled in theart that several further alternatives are possible. For example, thefeatures of the different embodiments discussed above could naturally becombined in many other ways. Specifically, the features and detailsdiscussed in relation to the different main aspects of the invention areusable also in relation to the other aspects, even though this may notbe specifically discussed in the exemplification. Further, the differentmain aspects of the invention are useable either separately or invarious combinations.

Further, different ways of connecting the receptacle with the catheterare possible, such as by welding, different types of adhesives, shrinkfits, etc. Further, it is possible to connect the receptacle to theconnector or to a part of the catheter tube, as long as the insertablepart of the catheter is arranged within the receptacle. In the latercase, the catheter need not even have a connector. The catheter may alsobe arranged to have more than one part at least partly protruding outfrom the receptacle, such as several connectors.

Further, the catheter need not be a hydrophilic catheter, but othertypes of catheters may be used as well. In that case, other types oflubricants may be used instead of the wetting fluid discussed inrelation to the above-disclosed embodiments. It is further possible touse the invention for other types of catheters than urinary catheters,such as vascular catheters or the like.

In case the catheter assembly comprises a wetting fluid container, it ispossible to arrange this container in many different ways. For example,the container may be a separate container. Such a container may bearranged completely inside the receptacle, partly inside the receptacle,or completely outside the receptacle. Alternatively, the wetting fluidcontainer may be an integrated compartment of the receptacle. Thiscompartment may be separated from the compartment housing the insertablepart of the catheter, or be integrated with such a compartment. In thelatter case, the catheter could be maintained in a wetted, activatedstate. Further, the wetting fluid container may be arranged close to thedistal part of the catheter, close to the proximal part of the catheter,or in any other suitable location in the assembly. In case the wettingfluid is arranged separate from the insertable part of the catheter, theseparation wall or joint could e.g. be a breakable or peelable membranewall, but alternative embodiments are naturally feasible, such asvarious types of detachable or openable caps or closings. The wettingfluid container could be arranged to be discharged upon application of atwist, a compression, a pull or the like on the fluid container.Preferably the wetting fluid could be discharged without breaking orrupturing the receptacle, even though this may not be necessary,depending on the intended use, etc.

Still further, the means for opening of the receptacle could be anysuitable opening means, such as tear lines, peelable joints, breakableareas of weakness, detachable or openable caps or closings, and thelike.

Many different materials could also be used for the different parts ofthe catheter assembly.

Ethylene sterilization could be used for sterilization of the catheterassemblies discussed above. However, many other types of sterilizationprocesses could of course be used instead, for example by irradiation inwhich case the fluid in the container could be sterilized in situ at thesame time as the rest of the components of the assembly. Steam treatmentmay also be used for sterilization.

It will be appreciated by those versed in the art that several suchalternatives similar to those described above could be used withoutdeparting from the spirit of the invention, and all such modificationsshould be regarded as a part of the present invention, as defined in theappended claims.

1. A catheter assembly comprising: a catheter, part of which forms aninsertable length to be inserted through a body opening; and a catheterreceptacle for accommodation of at least part of the catheter,characterized in that the receptacle is connected to the catheter,thereby enclosing the insertable length of the catheter, but leaving atleast part of the catheter outside the receptacle.
 2. The catheterassembly of claim 1, wherein the compartment formed by the receptacleand the catheter forms a microbial barrier towards the environment. 3.The catheter assembly of claim 1 or 2, wherein the catheter is ahydrophilic urinary catheter, and wherein the assembly further comprisesa wetting fluid.
 4. The catheter assembly of claim 3, wherein thewetting fluid is arranged in a compartment of the receptacle.
 5. Thecatheter assembly of claim 4, wherein the wetting fluid compartment isformed by a compartment of the receptacle housing the catheter, forpreservation of the hydrophilic surface layer in a wetted state duringaccommodation in said receptacle and provision of a ready-to-usecatheter assembly.
 6. The catheter assembly of claim 3, wherein thewetting fluid compartment is arranged to keep the wetting fluidseparated from at least an insertable part of the catheter duringstorage, the compartment container being openable for activation of thecatheter.
 7. The catheter assembly of claim 3, wherein the receptacle isgas impermeable.
 8. The catheter assembly of claim 3, wherein thewetting fluid container forms a compartment being separated from thereceptacle.
 9. A method for producing a catheter assembly, comprising:providing a receptacle having an opening; providing a catheter includinga catheter tube and a connector arranged on one end thereof; arrangingthe catheter tube in the receptacle; and connecting the receptacle tothe connector, thereby closing said opening.
 10. The method of claim 9,wherein the receptacle is connected to the connector thereby sealinglyclosing the receptacle.